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Alnylam’s LDL-Lowering Drug Positive in Phase II Study


Alnylam Pharmaceuticals, Inc. ALNY and its partner The Medicines Company MDCO announced positive final results from the phase II study, ORION-1, on their experimental PCSK9 inhibitor, inclisiran, which is being developed for the treatment of hypercholesterolemia.

Alnylam’s share price has increased 47.6% year to date, while the Zacks classified Medical Biomedical and Genetics industry gained 8%.

ORION-1 is a placebo-controlled, double-blinded, randomized, dose-finding phase II study. It compares and evaluates the effect of various doses of single or multiple subcutaneous injections of inclisiran. The study compares the effect of different doses of inclisiran and evaluates the potential for an infrequent dosing regimen.

The data from ORION-1 showed that inclisiran resulted in significant reductions of LDL-C (low-density lipoprotein ). Also, the study showed high standards of safety and tolerability.

The trial randomized 497 patients and the mean baseline LDL-C was about 130 mg/dL. The optimal starting dose regimen (300 mg injection administered on day-1 and day-90) achieved a mean LDL-C reduction of 52.6% and up to 81% at Day-180, and a time-adjusted mean of greater than 50% for the six month period from Day-90 through Day-270.

For all the dose groups the differences in the primary (LDL-C) and secondary (PCSK9) endpoints between inclisiran and placebo were statistically significant (p <0.0001). The results were presented at the American College of Cardiology’s 66th Annual Scientific Session, ACC.17, and have been published on Mar 17, 2017 online issue of The New England Journal of Medicine.

Moving ahead, the company expects to move Inclisiran into phase III development including the initiation of ORION-4.

In Jan 2017, The Medicines Company announced positive top-line results from a day 180 interim analysis of the ongoing ORION-1 phase II study on Inclisiran. The study was conducted in a total of 501 patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (hypercholesterolemia).

Moreover, the interim data demonstrated that inclisiran led to a significant and durable reduction of LDL (low-density lipoprotein) cholesterol up to Day 210. Inclisiran was well tolerated throughout the study, with infrequent and mild or moderate injection site reactions. Additionally, the company announced the initiation of ORION-2 for evaluating the efficacy, safety and tolerability of Inclisiran in patients with homozygous familial hypercholesterolemia (HoFH).

Zacks Rank & Other Key Picks

Alnylam is a Zacks Rank #3 (Hold) stock. Some other better-ranked stocks in the health care sector include Heska Corp. HSKA and Retrophin, Inc. RTRX. Heska and Retrophin carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%. Its share price increased 30% year to date.

Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018, over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.

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